Tesaro 3000-01-004: AN OPEN-LABEL, RANDOMIZED-SEQUENCE, MULTICENTER, SINGLE CROSSOVER STUDY TO ASSESS THE RELATIVE BIOAVAILABILITY AND

About this Study

The purpose of this study is to measure of how fast and how much of the study drug, Niraparib is available in the blood circulation after taking a dose. The study drug will be evaluated in both tablet and capsule form.

Sponsor Protocol ID:3000-01-004
IRB Number:2019-0210
Actively Enrolling
Interventional
Phase 1
November 25, 2019
Eligibility Criteria
18 years old
Both Male and Female
Yes
No
No

Inclusion CriteriaTo be considered eligible to participate in this study, all of the following requirements must be met: 

1. Patient is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements. 

2. Patient is at least 18 years of age. 

3. Patient is able to take oral medications. 

4. Male patient agrees to use an adequate method of contraception and not donate sperm starting with the first dose of study drug through 90 days after the last dose of study drug. 

Exclusion CriteriaPatients will not be eligible for study entry if any of the following criteria are met: 

1. Patient has a known diagnosis of immunodeficiency (Note: patients with splenectomy are allowed) 

2. Patient underwent major surgery within 3 weeks of starting the study or patient has not recovered from any effects of any major surgery. 

3. Patient is considered a poor medical risk due to a serious, uncontrolled medical disorder; nonmalignant systemic disease; or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, uncontrolled hypertension, active uncontrolled coagulopathy, bleeding disorder, or any psychiatric disorder that prohibits obtaining informed consent. 

4. Female patient is pregnant or is expecting to conceive children while receiving study drug or for up to 180 days after the last dose of study drug. Male patient is expecting to donate sperm or father children while receiving study drug or for up to 90 days after the last dose of study drug. 
a. Female patient is breastfeeding or is expecting to breastfeed within 30 days of receiving final dose of study drug (women should not breastfeed or store breastmilk for use, during treatment and for 30 days after receiving the final dose of study treatment). 

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Cancer
Participating Locations
Cancer Center and Research Institute
University Hospital
Contact Information
Contact Name: Jennifer Barnes
Phone Number: 601-815-4540
Email: jbarnes@umc.edu
Principal Investigator:Tang, Shou-Ching, M.D.
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